Embryo-Fetal Death and Severe Birth Defects
- Vismodegib (Erivedge) capsule can result in embryo-fetal death or severe birth defects.
- Vismodegib is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.
- Verify pregnancy status prior to the initiation of vismodegib (Erivedge).
- Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential of vismodegib (Erivedge) exposure through semen. [See Warnings and Precautions, Use in Specific Populations]
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Verify pregnancy status prior to initiation of the drug
- Counsel patients regarding teratogenicity risk
Patient Counseling Information
Updated January 2018